510(k) Report

Devices descending from K971910

472 later devices reach Multi-Parameter Module (M3000A)/Display Unit (M3046A) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K112652Suresigns VS2+ -Suresigns VsiPhilips Medical Systems201103
+4K102958Philips Avalon Fetal MonitorPhilips Medizin Systeme Boblingen GmbH20112—
+4K103700Essential Mri Patient MonitorInvivo Corporation20110—
+4K110287Philips Ecg Leadwire SetPhilips Medical Systems201151
+4K101133Sensometrics SoftwareDpcom AS20100—
+4K100420Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH20104—
+4K092549Oxiprobe, Models BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600PBio Medical Technologies Co., Ltd.20091—
+4K070791PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd.200747—
+4K060675Envitec Reusable Softip Y SPO2 SensorsEnvitec-Wismar GmbH20064—
+4K053234PM-9000 Express Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006711
+4K050128Vitalware VMSTelevital, Inc.20050—
+4K040259Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp.2004312—
+4K033513Easi Ecg AlgorithmPhilips Medical Systems2004220—
+5K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+5K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+5K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+5K253109Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)Shenzhen Best Electronics Co., Ltd.20260—
+5K251696Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2…Unimed Medical Supplies, Inc.20250—
+5K251691Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08…Unimed Medical Supplies, Inc.20250—
+5K251695Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06…Unimed Medical Supplies, Inc.20250—
+5K251693Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75…Unimed Medical Supplies, Inc.20250—
+5K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+5K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+5K242962Telemetry Monitor 5500 Release 4.0 (867232)Philips Medizin Systeme Böblingen GmbH202501
+5K242580Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2…Unimed Medical Supplies, Inc.20251—
+5K240271Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20241—
+5K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+5K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+5K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+5K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+5K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+Draeger Medical Systems, Inc.20231—
+5K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+5K223567CNS-2101 Central MonitorNihon Kohden Corporation20232—
+5K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+5K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+5K220117ARC Intensive Care Information System (ARC System)Ordinatrum Solutions20230—
+5K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+5K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+5K211046eCareManager 4.5Visicu, Inc.20220—
+5K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202231
+5K213335Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc.20223—
+5K212876Carescape SpO2 - MasimoMasimo Corporation20212—
+5K212227Philips MR Patient Care PortalInvivo Corporation202101
+5K210160AlertWatch:ACAlertwatch, Inc.20210—
+5K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+5K202851Spo2 SensorJkh USA, LLC20201—
+5K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+5K201360Reusable and Disposable SpO2 SensorsXinkang Medical Instrument Co., Ltd.20201—
+5K192514Patient MonitorEdan Instruments, Inc.202061
+5K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.20200—
+5K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+5K191279Disposable SpO2 SensorShenzhen Caremed Medical Technology Co., Ltd.20191—
+5K191420Reusable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20190—
+5K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+5K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+5K173941IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH20181—
+5K181270Disposable SpO2 Sensors, Reusable SpO2 SensorsOrantech, Inc.20181—
+5K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+5K172981Reusable SpO2 Sensors, Disposable SpO2 SensorsAPK Technology Co., Ltd.20180—
+5K173045OximeterShenzhen Greatmade Tech Limited20180—
+5K173715AlertWatch:OBAlertwatch, Inc.20180—
+5K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+5K162131ExSpiron 1XiRespiratory Motion, Inc.20173—
+5K163649SureSigns VS3; SureSigns VS4Philips Medical Systems2017110
+5K161056Telemetry TransmitterEdan Instruments, Inc.201702
+5K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems2016312
+5K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems201601
+5K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201661
+5K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+5K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+5K142489Unimed Disposable ECG lead wiresUnimed Medical Supplies, Inc.20144—
+5K132516Oxiprobe E (Oxiprobe)Bio Medical Technologies Co., Ltd.20140—
+5K123711Patient MonitorShenzhen Creative Industry Co., Ltd.201313—
+5K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+5K112877Comen Multi-Parameter Patient MonitorGoldway (Us), Inc.20121—
+5K121914Masimo Set USPO2 Pulse Oximetry CableMasimo Corporation201201
+5K102378Vectraplexecg System with VectraplexamiVectracor, Inc.20112—
+5K101690Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper CableSentec AG2010312
+5K100394Multi-Parameter Patient Monitor, Model# PMS8210AShanghai 3f Electronics Co, Ltd.20101—
+5K091834Passport V Monitor, Model 0998-00-6100Datascope Corp., Patient Monitoring Division200902
+5K082887PM-1000F+Patient MonitorAdvanced Instrumentations, Inc.20090—
+5K073280Beneview T Series Patient Monitors, Models T8, T6 and T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20082—
+5K080173STAR 55Larsen & Toubro Limited20085—
+5K072581PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd.200819—
+5K072346PM-7000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200719—
+5K061329Infinity Masimo Set SP02 PodDraeger Medical Systems, Inc.200625—
+5K041815LNCS Oximetry SensorsMasimo Corp.200486—
+6K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.20260—
+6K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+6K251751Spo2 Sensor CSS032DShenzhen Ykd Technology Co., Ltd.20250—
+6K250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20250—
+6K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+6K242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202502
+6K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+6K242750Central StationNihon Kohden Digital Health Solutions, LLC20251—
+6K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+6K241958WARD-CSS (v1.2.x)Ward 24/7 Aps20250—
+6K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+6K231979Mecun SpO2 sensorShenzhen Mecun Medical Supply Co., Ltd.20240—
+6K240312Infinity CentralStation WideDraeger Medical Systems, Inc.20240—